Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
FDA Recall Z-1731-2010 · Posted 2010-05-28
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2010-05-05
Date Terminated2010-06-01
Product Quantity96 units
Reason for Recall
Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
Firm Action
Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm.
For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution -- GA, IL, MO, NY, PA and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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